Shorter palliative radiotherapy for lung cancer
PARAT PAlliative RAdioTherapy to Lung Cancer A Randomized Multicentre Phase III Study
This study is testing if a shorter course of radiation treatment for lung cancer can help patients feel better and have fewer side effects compared to a longer treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT03632603 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two different palliative radiotherapy regimens for lung cancer patients, specifically evaluating a shorter treatment of 20 Gy over 4 fractions against a longer regimen of 30 Gy over 10 fractions. The primary focus is to determine if the shorter regimen can reduce early oesophageal toxicity while also assessing its impact on lung cancer symptoms, quality of life, and overall survival. The study seeks to standardize the quality of palliative thoracic radiotherapy across Danish centers, ensuring high technical standards. Patients with non-small-cell lung cancer or small-cell lung cancer who are not candidates for curative treatment will be included.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically or cytologically confirmed non-small-cell lung cancer or small-cell lung cancer at stages III-IV who are not eligible for curative treatment and have a performance status of 0-2.
Not a fit: Patients who have previously received thoracic radiotherapy that prevents them from safely undergoing the proposed treatment regimen will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved symptom management and quality of life for lung cancer patients with reduced treatment-related toxicity.
How similar studies have performed: Previous studies have indicated that palliative radiotherapy can improve quality of life in lung cancer patients, suggesting that this approach may build on established findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Histologically or cytologically confirmed NSCLC or SCLC. * Stages III-IV not candidates for curative treatment * Age ≥18 years. * Performance status: 0-2 * Signed informed consent. * Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use the pill, spiral, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch for the duration of study treatment and one month thereafter. Exclusion criteria: * Prior radiotherapy to the thorax that prohibits the delivery of 30 Gy/10 F with respect to OAR dose constraints. * Patients not able to understand the written or spoken information.
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Marianne Marquard Knap, PhD, MD
- Email: mariknap@rm.dk
- Phone: 0045 22985576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.